Menstrual Cycle Symptom Tracking

• Sponsor: SPD Development Company Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04756739
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

This study will provide menstrual cycle symptom information from women over the course of three menstrual cycles to determine whether there are any noticeable physiological changes that can be related to stage of the menstrual cycle or onset of menstruation.

Condition or Disease	Intervention/Treatment	Phase
Menstrual Cycles	Device: Clearblue Connected Ovulation Test System

Study Design

• Study Type: Observational
• Actual Enrollment: 104 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Menstrual Cycle Symptom Tracking Study
• Actual Study Start Date: Feb 22, 2021
• Actual Primary Completion Date: Sep 10, 2021
• Actual Study Completion Date: Sep 10, 2021

Outcome Measures

Primary Outcome Measures

1. Menstrual Cycle Symptoms [3 months]

   The primary objective of this study is to collect information from women on their experience of menstrual cycle symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Female

• Aged 18 years and over

• Regular menstrual cycles

• Owns a compatible smart phone i.e. iPhones® and AndroidTM phones equipped with Bluetooth® 4.0/BLE

• Willing to use their own smartphone for the duration of this study and to download and install the study app

• Willing to give informed consent

Exclusion Criteria:

• Currently trying to conceive

• Currently or recently pregnant or breastfeeding

• Taking any treatment which may affect the menstrual cycle (e.g. contraceptive pill, fertility medications or hormone replacement therapy)

• Taking or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)

• Has abnormal liver or kidney function

• Taking antibiotics containing tetracycline

• Taking clomiphene citrate or other ovulation induction drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SPD Development Company Ltd	Bedford	Bedfordshire	United Kingdom	MK44 3UP

Sponsors and Collaborators

• SPD Development Company Limited

Investigators

• Study Director: Sarah Johnson, PhD, SPD Development Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SPD Development Company Limited
• ClinicalTrials.gov Identifier: NCT04756739
• Other Study ID Numbers: PROTOCOL-1276
• First Posted: Feb 16, 2021
• Last Update Posted: Jan 12, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 12, 2022